Smartphone app to improve psychological wellbeing in Crohn's disease patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of the COBMINDEX application, designed to reduce psychological stress, fatigue, and pain in patients with Crohn's disease. Two groups of 200 patients will be randomly assigned to either a human therapist or a digital therapist using the app for a 3-month initial period, followed by 9 months of app usage for both groups. Daily assessments will track stress, pain, fatigue, and overall wellbeing, alongside evaluations of medical, psychological, and immunological status. The goal is to enhance quality of life and coping skills for patients living with Crohn's disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Willingness to participate and signed informed consent
* Hebrew-speaking
* Age 18-75
* Proven diagnosis of Crohn's disease, at least 3 months post-diagnosis
* Stable medical treatment for the last 3 months
* Any Harvey Bradshaw Index score
* Ability to operate a smartphone and cellular application

Exclusion Criteria:

* Diagnosis of ulcerative colitis or unclassified inflammatory bowel disease
* Planned surgery for Crohn's disease
* Surgery for Crohn's disease (excluding drainage of perianal abscess) in the last 3 months
* Psychiatric disease (schizophrenia, major depression or bipolar disorder)
* Alcohol or drug dependency (stable medical use of cannabinoids will be allowed)
* Pregnancy or planned pregnancy during study period
* Clinically significant comorbidity
* Former participation in COBMINDEX trials

Where it's running

• Soroka University Medical Center
  Beersheba, Israel Recruiting
• Rambam Health Care Campus i
  Haifa, Israel Not yet recruiting
• Belinson Medical Center
  Petah Tikva, Israel Not yet recruiting
• Sheba Medical Center
  Ramat Gan, Israel Not yet recruiting

Study contacts

• Study coordinator: Doron Schwartz, MD
• Email: DoronSh@clalit.org.il
• Phone: +972-52-3919044

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.